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Gut bacteria drink may boost heart function, study finds

NCT ID NCT03267758

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether taking a daily probiotic drink called Goodbelly for 6 weeks could improve blood vessel function and reduce inflammation in 215 adults with heart disease or type 2 diabetes. Researchers measured blood markers and gut bacteria to see if the probiotic made a difference. The goal was to find a simple way to lower heart attack risk by changing the bacteria in the gut.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Goodbelly probiotic (dietary supplement)
What this could lead to
If it works, this could point toward a simple probiotic supplement to help manage heart disease risk by improving blood vessel function and reducing inflammation.
What could go wrong
This is a small, completed trial with no phase designation, so results may not be conclusive. The probiotic is a dietary supplement, not a drug, so any benefits are likely modest and not a replacement for standard treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

215 people

The number who actually took part.

Started

May 2018

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

CAD Inclusion Criteria Age between 40-80 years old History of known coronary artery disease (by either history of myocardial infarction, angiogram demonstrative \>=50% stenosis in at least 1 major epicardial coronary artery, or a previous stress test that showed evidence of ischemia that has not been revealed to be a false positive test by angiography) T2DM without CAD Inclusion Criteria 1. Age between 40-80 years old 2. History of known Diabetes Mellitus Type II as previously diagnosed by patient's provider (ICD-9/10 code) CAD Exclusion Criteria Unstable angina or myocardial infarction by history, ECG, and/or enzymatic criteria within 1 month of enrollment. LV dysfunction as defined by an LV ejection fraction documented as \< 45% within 1 year of enrollment by an echocardiogram, MRI, or nuclear imaging. Uncontrolled hypertension with a blood pressure greater than 170/100 mmHg at the screening visit. Known history of chronic renal insufficiency, liver dysfunction, or cancer besides non-melanoma skin carcinomas or localized prostate cancer requiring systemic treatment within five years of enrollment. Known history of cognitive impairment or inability to follow study procedures Patient with GI tract illness such as short gut syndrome, inflammatory bowel disease, or an ileostomy. Patient with an implanted defibrillator or permanent pacemaker on which the potential participant is known to rely upon for greater than 50% of ventricular depolarizations. Patients who received probiotics, prebiotics, and antibiotics in the last 12 weeks. Patients with dosing changes of vasoactive medications and HMG-CoA reductase inhibitors in the 6 weeks prior to enrollment. Pregnancy Patients who is currently taking Vitamin K anatagonists such as coumadin, warfarin. Those who are daily drinkers or use illicit drugs. T2DM without CAD Exclusion Criteria Hgb A1C \> 9.5 % Coronary Artery Disease (by either history of myocardial infarction, angiogram demonstrative \>=50% stenosis in at least 1 major epicardial coronary artery, or a previous stress test that showed evidence of ischemia that has not been revealed to be a false positive test by angiography) Unstable angina or myocardial infarction by history, ECG, and/or enzymatic criteria within 1 month of enrollment. LV dysfunction as defined by an LV ejection fraction documented as \< 45% within 1 year of enrollment by an echocardiogram, MRI, or nuclear imaging. Uncontrolled hypertension with a blood pressure greater than 170/100 mmHg at the screening visit. Known history of chronic renal insufficiency, liver dysfunction, or cancer besides non-melanoma skin carcinomas or localized prostate cancer requiring systemic treatment within five years of enrollment. Known history of cognitive impairment or inability to follow study procedures Patient with GI tract illness such as short gut syndrome, inflammatory bowel disease, or an ileostomy. Patient with an implanted defibrillator or permanent pacemaker on which the potential participant is known to rely upon for greater than 50% of ventricular depolarizations. Patients who received probiotics, prebiotics, and antibiotics in the last 12 weeks. Patients with dosing changes of vasoactive medications and HMG-CoA reductase inhibitors in the 6 weeks prior to enrollment. Pregnancy Patients who is currently taking Vitamin K anatagonists such as coumadin, warfarin. Those who are daily drinkers or use illicit drugs.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.